EU Authorized Representative (AR)
From AR registration to technical file custody and authority liaison — your Article 11 MDR obligations covered under an annual agreement.
Typical challenges
- An Authorized Representative in the EU is required
- No structure for technical file custody and authority liaison
- Concerns about incident and recall handling
What we provide
- AR registration & labelling
- AR mandate and AR details on labels/IFU
- Technical file custody
- Custody of current technical documentation, provided to authorities upon request
- Authority liaison
- First point of contact for EU authority enquiries
- Incident & recall support
- Support for serious post-market events (optional add-on)
How we work
- 1Agreement & AR registration
- 2Receipt & custody of technical documentation
- 3Ongoing authority liaison
- 4Continued post-market support
Related services
Start with a free 30-minute consultation
We help you map your current position: device class, CE status, and EU clinical investigation plans.
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